MAUDE Adverse Event Report: MYLAN PHARMACEUTICALS INC. EPIPEN; INJECTOR, PEN

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2020

Event Type  Injury  

Event Description

I noticed that the blue part of my epipen was already raised even though it has never been removed from its case until today to check if it fell into the group in the epipen failure group.Fda safety report id# (b)(4).

• Brand Name: EPIPEN
• Type of Device: INJECTOR, PEN
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 9902658
• MDR Text Key: 185926952
• Report Number: MW5093970
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 86